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NCT Number: NCT06924658

Metformin in Safety and Efficacy in Gouty Patients

The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Gout and its associated diseases have been shown to have a significant impact on patients mortality and morbidities. Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tanta Unuversity

Tanta, 31527, Egypt

Location status: Recruiting

Location contact

Mostafa M Bahaa, PhD

SUB_INVESTIGATOR

Mostafa M I Bahaa, PhD

CONTACT

[email protected]

0201025538337

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gouty patients clinically diagnosed as gouty arthritis based on the American College of Rheumatology/European League Against Rheumatism criteria of gout.

Exclusion criteria

  • Systemic disorders such as cardiovascular, neurological, coronary artery disease.
  • Hypertension, hyperlipidemia, diabetes mellitus, active infections.
  • Other inflammatory or autoimmune diseases.
  • Patients on biologics,
  • Cases with hypersensitivity to metformin and those with impaired liver and kidney functions.

Treatment and study plan

Placebo

Other

Placebo will have the same look of metformin

metformin

Drug

Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients

Primary outcomes

  1. - Clinical assessment of disease activity

    Time frame: 3 months

    • Clinical assessment of disease activity by assessing patient and physician VAS visual analog scale (0-10 cm);

Sponsors and collaborators

Lead sponsor

Mostafa Bahaa

Other

Registry information

Official study title

the Impact of Metformin Use on Clinical Outcomes in Gouty Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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